PRO-CEFUROXIME - 500 TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
23-09-2019
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ingredients actius:
CEFUROXIME (CEFUROXIME AXETIL)
Disponible des:
PRO DOC LIMITEE
Codi ATC:
J01DC02
Designació comuna internacional (DCI):
CEFUROXIME
Dosis:
500MG
formulario farmacéutico:
TABLET
Composición:
CEFUROXIME (CEFUROXIME AXETIL) 500MG
Vía de administración:
ORAL
Unidades en paquete:
100
tipo de receta:
Prescription
Área terapéutica:
SECOND GENERATION CEPHALOSPORINS
Resumen del producto:
Active ingredient group (AIG) number: 0122448002; AHFS:
Estat d'Autorització:
CANCELLED POST MARKET
Data d'autorització:
2021-05-31
Fitxa tècnica
Page 1 of 27
PRODUCT MONOGRAPH
PR
PRO-CEFUROXIME - 500
CEFUROXIME AXETIL TABLETS, USP
500 MG CEFUROXIME / TABLET
ANTIBIOTIC
PRO DOC LTÉE
DATE OF REVISION:
2925, boul. Industriel
September 23, 2019
Laval, Quebec
H7L 3W9
CONTROL NO.: 229806
Page 2 of 27
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
.......................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................
4
ADVERSE REACTIONS
......................................................................................................
6
DRUG INTERACTIONS
.......................................................................................................
7
DOSAGE AND ADMINISTRATION
......................................................................................
8
OVERDOSAGE
....................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
9
STORAGE AND
STABILITY.................................................................................................
9
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 9
PART II: SCIENTIFIC INFORMATION
....................................................................................10
PHARMACEUTICAL INFORMATION
..................................................................................10
CLINICAL TRIALS
...............................................................................................................11
DETAILED PHARMACOLOGY
....
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